A Phase 2, Open-Label Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer

NCT01357395 | Completed Phase 2

• 2 other identifiers: SGI-0470-072010-024378-21
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 12

Brief Summary

The purpose of the study is to evaluate the safety and potential benefit of combination amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small cell lung cancer (SCLC) subjects.

Conditions

Small Cell Lung Carcinoma

Keywords

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall objective response rate (CR or PR)

  3 months

Secondary Outcomes (6)

• Progression-free survival and overall survival

  6 months

• Disease control rate

  6 months

• Duration of response

  6 months

• Safety and tolerability

  6 months

• Amuvatinib and metabolites PK and other biomarkers

  6 months

Study Arms (1)

Amuvatinib

EXPERIMENTAL

Amuvatinib 300 mg PO TID + standard-of-care platinum-etoposide

Drug: Amuvatinib

Interventions

Amuvatinib DRUG

Amuvatinib 300 mg PO TID

Also known as: MP-470

Amuvatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 of age at the time of consent and have histologically or cytologically confirmed SCLC
• Measurable SCLC per RECIST guideline that meets one of the following:
• Disease progression by RECIST at anytime during platinum-etoposide (PE) chemotherapy;
• Relapse by RECIST within 90 days after completing PE chemotherapy;
• Stable disease by RECIST as best response after at least two (2) ≥ 21-day cycles of PE chemotherapy. The assessment of stable disease should be made at least 2 weeks after the start of the second cycle
• Subjects who received another second-line therapy are eligible if they still fulfill any one of the above three conditions, and all other eligibility criteria
• Start treatment with the same last regimen (dose and schedule) of first-line PE chemotherapy that they progressed or relapsed on, including any dose reductions because of toxicity, prior to study entry
• ECOG performance status 0 to 2
• Adequate organ function
• Subjects with screening 12-lead ECG with measurable QTc interval of \< 450 msec. If QTc ≥ 450 msec, then confirm the reading by evaluating the mean QTc interval of triplicate ECGs.
• Sign approved informed consent form

You may not qualify if:

• Prior exposure to amuvatinib
• No longer eligible for first-line PE chemotherapy due to toxicity and the Investigator believes that the risk of retreating with the same PE chemotherapy regimen would outweigh the benefit
• Ongoing toxicity from prior treatment unless the toxicity has resolved, or in the opinion of the Investigator, is stable and does not compromise the safety of the subject
• Mixed SCLC and non-small cell lung cancer, or large cell lung cancer
• Untreated, unstable, or symptomatic brain metastasis
• Hypersensitivity to amuvatinib, excipients of amuvatinib, or any agent given in association with this trial
• A life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or interfere with study outcomes

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (12)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, 40202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Associates in Oncology and Hematology

Chattanooga, Tennessee, 37404, United States

Location

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Wojewódzki Szpital Specjalistyczny

Radom, Masovian Voivodeship, 26-617, Poland

Location

Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

Location

Wojewódzkie Centrum Onkologii

Gdansk, Pomeranian Voivodeship, 80-219, Poland

Location

Specjalistyczny Szpital im. Alfreda Sokolowskiego

Szczecin, West Pomeranian Voivodeship, 70-891, Poland

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

amuvatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: May 20, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 28, 2012
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

US (7); PL (5)